To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir [ Time Frame: Screening and Days 1, 5, 15, 19, 29 and 33. ] [ Designated as safety issue: Yes ]

Determination of pharmacokinetic parameters [ Time Frame: at each sampling time ] [ Designated as safety issue: No ]

To evaluate the safety of combined use of pravastatin and raltegravir [ Time Frame: entire trial ] [ Designated as safety issue: Yes ]

Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.

Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.

Eligibility

Ages Eligible for Study:

18 Years to 55 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subject is at least 18 and not older than 55 years of age.

Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.

Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.

Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Subject is in good age-appropriate health condition.

Subject has a normal blood pressure and pulse rate.

Exclusion Criteria:

Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.

Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

History of or current abuse of drugs, alcohol or solvents.

Inability to understand the nature and extent of the trial and the procedures required.

Participation in a drug trial within 60 days prior to the first dose.

Donation of blood within 60 days prior to the first dose.

Febrile illness within 3 days before the first dose

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665717